At the Drug Day on "The future of drugs in Italy", chaired by Prof. R. Paoletti in Milan on November 12, one of the two Galeno Lifetime Achievement Awards was assigned to dr. Nello Martini, general director of AIFA, also registered among the speakers of the Round Table on the theme of the meeting. Martini outlined an overview of the Italian pharmaceutical situation: phases I and II of clinical trials, despite the significant steps taken, still represent a marginal situation; we do not see enough resistance towards the Indian and Chinese markets, especially in terms of product quality. Bearing in mind the two current variables, i.e. population aging and technological progress, we all need to share a platform to make medicines a fundamental point of welfare policies. In recent years there have been three historical phases: the first, ideological, with the drug-market contrast (on the one hand the expenditure to be contained, on the other the lobby); the second (2001-2007) with the imperative of government spending and its containment; however, in 2007 we managed to close cash and competence together, as the administrators say, and we are therefore in a position to be able to implement a reform that considers the drug an element of development of the system, always within the framework of a welfare policy. However, no one can act alone, sharing is needed. And therefore a "Table" was created to re-establish the launch platform. Fundamental elements are: the guarantee of stability, at state and regional level; the certainty of being able to plan. Financial resources are on the rise. There will be no interventions on prices, possibly only on pay-back. An Innovation Fund has been prefigured, partially funded by the National Health Fund. From 2008 there will be availability due to expiry of patents and the new resources will be aimed at innovation and the increase of the market. So here are the new concepts to share: non-intervention on prices, stability, innovation. Some application proposals are already ready and will be launched as soon as possible. Our market, fifth in the world in terms of turnover, must also become so in terms of research and development. However, bearing in mind that the paradigms of research are changing: genomics and engineered cells will break into the terrain of combinatorial chemistry and biotechnology. In the next few years we will have the spin off! Another important concept to consider is that current clinical trials often bring medicines to the market that would still have to be studied (efficacy, safety, effects on the elderly and other special categories of patients). The post-marketing phase can become a true research phase. And here also the companies will have to modify some of their structures. Finally we will have to face the problem of which drugs the state has to pay for: those that give results. So, having concluded the first two phases of our recent pharmaceutical history, we are entering the third, which must make the drug, as well as a health tool, an element of development for the country.
NCF dated 30/01/2008 DECEMBER 2007 p. 14
